BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION

    MDR report key: 2626962 · Received June 21, 2012

    Report

    Report Number
    1119779-2012-00006
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    May 25, 2012
    Report Date
    May 29, 2012
    Manufacturer
    BECTON, DICKINSON DIAGNOTIC SYSTEMS
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE MSDS, IT WAS DETERMINED THAT THERE ARE NO SUBSTANCES IN THE ESWAB THAT WOULD BE HARMFUL TO THE SKIN OR EYES. THERE ARE RISKS ASSOCIATED WITH BEING SPLASHED WITH MATERIAL THAT CONTAINS BLOOD OR BODY FLUIDS. IN THIS CASE, THE ESWAB HAD BEEN USED TO COLLECT VAGINAL SPECIMEN, WHICH COULD CONTAIN BLOODBORNE PATHOGENS SUCH AS HIV, HBV, OR HCV AS WELL AS BACTERIAL PATHOGENS, SUCH AS , CHLAMYDIA TRACHOMATIS OR NEISSERIA GONORRHOEAE. THERE IS ALSO A RISK THAT BACTERIAL PATHOGENS INTRODUCED INTO THE EYE VIA THE SPLASH COULD RESULT IN INFECTION. THE PHYSICIAN DIDN'T RINSE THEIR EYE AND DIDN'T SEEK FURTHER POST-EXPOSURE PROPHYLAXIS OR WORK-UP. TO DATE, BD HAS NO FOLLOW UP TO SUGGEST THAT THERE WERE ANY ADVERSE HEALTH CONSEQUENCES FROM THIS INCIDENT. THE WARNINGS AND PRECAUTIONS STATED IN THE BD LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT PACKAGE INSERT INCLUDE: OBSERVE APPROVED BIOHAZARD PRECAUTIONS AND ASEPTIC TECHNIQUES. PATHOGENIC MICROORGANISMS, INCLUDING HEPATITIS VIRUSES AND HUMAN IMMUNODEFICIENCY VIRUS, MAY BE PRESENT IN CLINICAL SPECIMENS. "STANDARD PRECAUTIONS" AND INSTITUTIONAL GUIDELINES SHOULD BE FOLLOWED IN HANDLING ALL ITEMS CONTAMINATED WITH BLOOD AND OTHER BODY FLUIDS. REPORT GENERATED DUE TO EXPOSURE OF A MUCOSAL SURFACE TO MATERIAL WHICH COULD CONTAIN BLOOD AND/OR BODY FLUIDS. THERE ARE NO COMPLAINT TRENDS FOR THIS TYPE OF INCIDENT. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A DR WAS USING THIS PRODUCT TO COLLECT A VAGINAL SPECIMEN. AFTER SPECIMEN COLLECTION WHILE THE DOCTOR WAS PUTTING THE SWAB INTO THE TUBE, SOME OF THE TRANSPORT MEDICAL SPLASHED ON HER FACE AND GOT IN HER EYES WHEN SHE WENT TO BREAK THE SWAB. THE DR DID NOT RINSE HER EYE WITH WATER OR ADMINISTER ANY ADD'L FIRST AID. THE DR WAS NOT WEARING ANY PPE FOR HER FACE. BD WAS CONTACTED TO OBTAIN INFO FROM THE MSDS FOR THE TRANSPORT MEDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION JTW BECTON, DICKINSON DIAGNOTIC SYSTEMS 6FRJ45

    Patients

    Seq Age Sex Outcome Treatment
    1 Other